A multi-stakeholder meeting took place with European Union officials on 6 September 2023. It covered the implications of the potential adoption of an opt-out option to the secondary uses of health data in the European Health Data Space. EHTEL was among the attendees.
What’s in the European Health Data Space for me?
Ultimately, understanding the European Health Data Space has to offer will help you to:
- Assess how public health in Europe will benefit from the potential access to real world data that the space permits.
More specifically, with regard to these recent multi-stakeholder discussions, you can:
- Understand the state-of-play on the European Health Data Space ahead of its official announcement.
- Follow how the primary use of citizens'/patients' data fits with the secondary use of data for other purposes.
- Capture how at least one stakeholder group or forum is assisting with European policy development.
Read a summary and detailed report of the meeting in the Resources section below. ⤵️
From a consensus statement to a meeting:
A multiple-stakeholder group has already signed a joint consensus statement on its position on the European Health Data Space (EHDS).
On 6 September 2023 the multi-stakeholder group, representing 32 organisations from the European healthcare community, met to discuss the European Health Data Space (EHDS). The group covered how the EHDS could facilitate secondary use of personal electronic health data to create tangible benefits for patients and society. The European officials involved included MEP Sokol, Co-Rapporteur of one of the relevant health-related parliamentary committees, and other European Parliament officials, as well as representatives of the current trio of presidencies of Council.
The stakeholder group understands the spirit of protecting the interests of natural persons from improper secondary use of personal electronic health data. Yet the group also fears the unintentional side-effects of implementing either an opt-out or an opt-in mechanism.
An expression of concerns:
In line with its joint consensus statement of June 2023, the multi-stakeholder group expressed concern about three issues. They were the possible scope of an opt-out mechanism, the challenges of ensuring inclusivity and equity, and a number of related operational challenges. The group reiterated its concern that the risk posed by such a mechanism is that it may amplify data bias rather than help to correct it. It may exaggerate inequalities and disparities through incorrect inferences being drawn from the data, and lead to health strategies and treatments that are poorly suited to certain groups.
Specific areas being discussed in the European Parliament raise concerns. On the one hand, there is a potential political compromise to introduce an opt-out mechanism combined with an opt-in for certain categories of data, such as data from biobanks or genetic data. The exact scope of an opt-out mechanism has not yet been detailed. There is ongoing discussion about what can be achieved by the proposed Regulation and what should be detailed in implementing acts. On the other hand, Member States may be reluctant to accept a detailed top-down prescription of an opt-out mechanism for both technical and political reasons. However, no prevailing view was expressed on whether an opt-out would be applied only to the EHDS2 mechanism – the infrastructure for the secondary use of health data – or whether it would have implications for all secondary use of personal electronic health data.
During the meeting, several organisations with mandates on biobanks, cancer, and cardiology spoke about their detailed preoccupations. These related to:
- The need for social and cultural change backed by patients.
- Possible biases in the collection of data.
- The implementation of a governance mechanism that will ensure trust in the data space.
- The filling of gaps in evidence that form barriers to effective policy-making.
On a positive note:
The European Union (EU) officials agreed that it would be important to ensure that the EHDS does not exacerbate data bias. The officials acknowledged that, had there been more and better use of data by national authorities, it may have led to fewer mistakes in health-related policy making during the COVID-19 pandemic. They called for significantly more funding and incentives in four areas – digitalisation, infrastructure development, interoperability, and training – to support the implementation of the EHDS. There was also consensus among officials that the timeline for implementation of the space will need to be extended.